King Pharma resubmits abuse-resistant oxycodone to FDA

Two years after receiving a Complete Response letter from FDA about Remoxy, King Pharmaceuticals and Pain Therapeutics announced that they had resubmitted the drug for approval yesterday. A thumbs up or thumbs down from FDA is expected in June.

If approved, Remoxy would go head-to-head against Purdue's blockbuster pain drug OxyContin, both of which contain the active ingredient oxycodone, a schedule 2 narcotic. Remoxy, however, would be able to tout its tamper-resistant capabilities, if approved. Asked whether Remoxy's safety profile would help the drug skirt patent concerns, Jack Howarth, VP investor relations at King Pharmaceuticals – a Tennessee-based pharma that picked up commercialization rights to Remoxy in 2005 – said “FDA wants companies to develop safer products all around,” not just safer pain drugs.

Howarth declined to discuss Remoxy's specific delivery mechanism, saying that King Pharma and Pain Therapeutics are keeping details under wraps, since “the more we say, the more Purdue knows.” To address safety concerns, Purdue reformulated OxyContin earlier this year, and FDA approved the new version in April. Postmarket studies were required to determine the extent to which the new formulation of OxyContin reduces abuse and misuse, according to an FDA statement.

Remoxy, a twice-daily oral formulation, was developed by Pain Therapeutics using Durect Corporation's Oradur technology, a gelatin capsule “that uses a high-viscosity base component such as sucrose acetate isobutyrate to provide controlled release of active ingredient or a period of 12 to 24 hours of drug delivery,” according to Durect's website. Pfizer announced that it would acquire King Pharma for $3.6 billion in October.